Avoclod

Poland
Brand name Avoclod
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100474106
Manufacturer Pharmadox Healthcare Limited

Table of Contents

Package leaflet: Information for the

user
Avoclod, 2.5 mg, coated tablets
apixaban
Read the entire leaflet carefully before taking this medicine, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

  1. What Avoclod is and what it is used for
  2. Important information before taking Avoclod
  3. How to take Avoclod
  4. Possible side effects
  5. How to store Avoclod
  6. Contents of the pack and other information

1. What Avoclod is and what it is used for

Avoclod contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by inhibiting factor Xa, an important component in the blood clotting process.

Avoclod is used in adults:

  • To prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients may have an increased risk of developing blood clots in the veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
  • To prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or to other organs, impairing blood supply to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical attention.
  • To treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent recurrence of blood clots in the veins and/or lungs.

Avoclod is used in children aged from 28 days up to below 18 years for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
Information regarding body weight and recommended dosage can be found in section 3.

2. Important information before using Avoclod

When not to use Avoclod

  • if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
  • if the patient has active bleeding,
  • if the patient has a condition that increases the risk of major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial bleeding),
  • if the patient has liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
  • if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations of switching anticoagulant therapy, when a venous or arterial line has been inserted and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting treatment with Avoclod, discuss with the doctor, pharmacist or nurse if the patient has any of the following conditions:

  • increased risk of bleeding, for example:
  • conditions associated with bleeding, including those resulting in reduced platelet function,
  • very high blood pressure not controlled by medication,
  • if the patient is over 75 years of age,
  • if the patient weighs 60 kg or less,
  • severe kidney disease or if the patient is on dialysis,
  • liver disease or history of liver disease. This medicine should be used with caution in patients showing signs of impaired liver function.
  • a spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine at least 5 or more hours after catheter removal,
  • if the patient has a heart valve prosthesis,
  • if the doctor determines that the patient's blood pressure is unstable,
  • if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Avoclod

  • if the patient has a disorder known as antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed.

If surgery or a procedure associated with bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a procedure may involve bleeding, ask the doctor.

Children and adolescents
Avoclod is not recommended for use in children and adolescents under 18 years of age with body weight below 35 kg.

Avoclod and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Some medicines may enhance the effect of Avoclod, while others may reduce it. The doctor will decide whether the patient should receive Avoclod while taking other medicines and how closely monitoring should be performed.

The following medicines may enhance the effect of Avoclod and increase the risk of unwanted bleeding:

  • certain antifungal medicines (e.g. ketoconazole and others),
  • certain antiviral medicines used to treat HIV/AIDS infection (e.g. ritonavir),
  • other medicines used to reduce blood clotting (e.g. enoxaparin and others),
  • non-steroidal anti-inflammatory drugs or painkillers (e.g. acetylsalicylic acid or naproxen); particularly if the patient is over 75 years old and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased,
  • medicines used to treat high blood pressure or heart problems (e.g. diltiazem),
  • antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Avoclod to prevent blood clots:

  • medicines used to prevent epilepsy or seizures (e.g. phenytoin and others),
  • St John’s wort (an herbal supplement used for depression),
  • medicines used to treat tuberculosis or other infections (e.g. rifampicin).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

The effect of apixaban on pregnancy and the unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.

It is not known whether apixaban passes into human milk. The patient should consult her doctor, pharmacist or nurse before taking this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting treatment with this medicine.

Driving and using machines
Apixaban has no or negligible influence on the ability to drive and use machines.

Avoclod contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Avoclod

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed whole with water. Avoclod can be taken independently of meals.
To achieve the best treatment outcomes, it is recommended to take the tablets at the same time each day.
If a patient has difficulty swallowing tablets whole, they should discuss alternative methods of taking Avoclod with their doctor. The tablet may be crushed immediately before administration
and mixed with water or 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:

  • Crush the tablet with a mortar and pestle.
  • Carefully transfer the powder to a suitable container, then mix it with a small amount, e.g., 30 mL (2 tablespoons) of water or another liquid listed above to prepare a mixture.
  • Swallow the mixture.
  • Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), and swallow the rinsing liquid.

If necessary, your doctor may administer crushed Avoclod tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Avoclod should be taken as recommended for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Avoclod tablet twice daily. For example,
one tablet in the morning and one in the evening.
The first tablet should be taken 12 to 24 hours after surgery.
If the patient has undergone major hip surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor
The recommended dose is one 5 mg Avoclod tablet twice daily.
The recommended dose is one 2.5 mg Avoclod tablet twice daily if:

  • the patient has severe renal impairment,
  • two or more of the following conditions are met:
  • blood test results suggest reduced kidney function (serum creatinine concentration of 1.5 mg/dL (133 micromoles/L) or higher),
  • the patient is 80 years of age or older,
  • the patient’s body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg Avoclod tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one 5 mg Avoclod tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one 2.5 mg Avoclod tablet twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrence of blood clots in veins or in blood vessels of the lungs.
This medicine should always be taken or administered as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor, pharmacist, or nurse.
To achieve the best treatment outcome, the dose should be taken or administered at the same time each day.
The dose of Avoclod depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four 2.5 mg Avoclod tablets, administered twice daily for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two 2.5 mg Avoclod tablets, administered twice daily, for example, two in the morning and two in the evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary due to changes in the patient’s body weight.
Your doctor may change anticoagulant treatment as follows:

  • Switching from Avoclod to anticoagulant medicines Discontinue Avoclod. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.
  • Switching from anticoagulant medicines to Avoclod Discontinue anticoagulant medicines. Start Avoclod at the time the next dose of anticoagulant medicine was scheduled, then continue taking it as usual.
  • Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Avoclod Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to start taking Avoclod.
  • Switching from Avoclod to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If your doctor informs you that you should start taking a medicine containing a vitamin K antagonist, continue taking Avoclod for at least 2 days after taking the first dose of the vitamin K antagonist medicine.

Your doctor must perform blood tests and inform you when to stop taking Avoclod.
Patients undergoing cardioversion
Patients who require a cardioversion procedure to restore normal heart rhythm should take this medicine at the times specified by their doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels in the body.
Taking more Avoclod than recommended
If a patient has taken more than the recommended dose of this medicine, you should contact your doctor immediately. Take the medicine packaging with you, even if it is empty.
If a patient has taken more than the recommended dose of Avoclod, there may be an increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect directed against factor Xa may be necessary.
Missing a dose of Avoclod

  • If a morning dose is missed, take it as soon as remembered, and it may be taken together with the evening dose.
  • A missed evening dose may only be taken the same evening. Do not take two doses the next morning instead; continue taking the medicine the next day as recommended, twice daily. If you have any doubts about using the medicine or if you miss more than one dose, consult your doctor, pharmacist, or nurse.

Stopping Avoclod
Do not stop taking this medicine without consulting your doctor, as stopping Avoclod prematurely may increase the risk of blood clots.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

The medicine Avoclod can be used in three different medical conditions. Known adverse reactions and their frequency of occurrence in each of these medical conditions may differ and are listed separately below. In these conditions, the most common general adverse reaction associated with this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse reactions may occur when taking Avoclod to prevent blood clots after hip or knee surgery.

Common adverse reactions (may occur in up to 1 in 10 people)

  • Anaemia, which may cause fatigue or paleness;
  • Bleeding including:
    • Subcutaneous haemorrhages and swelling;
  • Nausea.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

  • Reduced platelet count (which may affect blood clotting);
  • Bleeding:
    • Post-surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
    • From the stomach, intestines, or bright red blood in stool;
    • Blood in urine;
    • Nosebleeds;
    • Vaginal bleeding;
  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Blood test results may indicate:
    • Liver function abnormalities;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels, a product formed from destroyed red blood cells, which may cause yellowing of the skin and eyes;
  • Itching.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

  • Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately;
  • Bleeding:
    • Into muscle tissue;
    • Into the eyes;
    • From gums and coughing up blood;
    • From the rectum;
  • Hair loss.

Frequency unknown (frequency cannot be estimated from available data)

  • Bleeding:
    • Into the brain or spinal cord;
    • In the lungs or throat;
    • In the mouth;
    • Into the abdominal cavity or retroperitoneal space;
    • From haemorrhoids;
    • Test results indicating presence of blood in stool or urine;
  • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring and a dark ring around the edge) (erythema multiforme);
  • Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking Avoclod to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common adverse reactions (may occur in up to 1 in 10 people)

  • Bleeding, including:
    • Into the eye;
    • Into the stomach or intestine;
    • From the rectum;
    • Blood in urine;
    • Nosebleeds;
    • From gums;
    • Subcutaneous haemorrhage and swelling;
  • Anaemia, which may cause fatigue or paleness;
  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Nausea;
  • Blood test results may indicate:
    • Increased gamma-glutamyl transferase (GGT) activity.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

  • Bleeding:
    • Into the brain or spinal cord;
    • In the mouth or haemoptysis (coughing up blood);
    • Into the abdominal cavity or from the vagina;
    • Bright red blood in stool;
    • Post-surgical bleeding, including bruising and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site;
    • From haemorrhoids;
    • Presence of blood in stool or urine detected in laboratory tests;
  • Decreased platelet count (which may affect blood clotting);
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
  • Skin rash;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

  • Bleeding:
    • In the lungs or throat;
    • Into the retroperitoneal space;
    • Into muscles.

Very rare adverse reactions (may occur in up to 1 in 10,000 people)

  • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring and a dark ring around the edge) (erythema multiforme).

Frequency unknown (frequency cannot be estimated from available data)

  • Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking Avoclod to treat or prevent recurrence of blood clots in the veins of the lower limbs and blood clots in blood vessels of the lungs.

Common adverse reactions (may occur in up to 1 in 10 people)

  • Bleeding, including:
    • Nosebleeds;
    • From gums;
    • Blood in urine;
    • Subcutaneous haemorrhage and swelling;
    • In the stomach, intestine, or from the rectum;
    • In the mouth;
    • From the vagina;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect clotting);
  • Nausea;
  • Skin rash;
  • Blood test results may indicate:
    • Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Bleeding:
    • Into the eyes;
    • In the mouth or coughing up blood;
    • Bright red blood in stool;
    • Test results indicating blood in stool or urine;
    • Post-surgical bleeding, including bruising and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site;
    • From haemorrhoids;
    • Into muscles;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately;
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

  • Bleeding:
    • Into the brain or spinal cord;
    • In the lungs.

Frequency unknown (frequency cannot be estimated from available data)

  • Bleeding:
    • Into the abdominal cavity or retroperitoneal space;
  • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring and a dark ring around the edge) (erythema multiforme);
  • Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse reactions in children and adolescents

If any of the following symptoms occur, contact your doctor immediately:

  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these adverse reactions is classified as "common" (may occur in up to 1 in 10 people).

In general, adverse reactions observed in children and adolescents treated with Avoclod were similar to those seen in adults and were mostly mild or moderate in severity. Adverse reactions occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

Very common adverse reactions (may occur in more than 1 in 10 people)

  • Bleeding, including:
    • From the vagina;
    • Nosebleeds.

Common adverse reactions (may occur in up to 1 in 10 people)

  • Bleeding, including:
    • From gums;
    • Blood in urine;
    • Subcutaneous haemorrhages (bruising) and swelling;
    • From the intestine or rectum;
    • Bright red blood in stool;
    • Post-surgical bleeding, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood (discharge) from the surgical wound or injection site;
  • Hair loss;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect coagulation);
  • Nausea;
  • Skin rash;
  • Itching;
  • Low blood pressure, which may cause fainting or rapid heartbeat;
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased alanine aminotransferase (ALT) activity.

Frequency unknown (cannot be estimated from available data)

  • Bleeding:
    • Into the abdominal cavity or retroperitoneal space;
    • In the stomach;
    • In the eyes;
    • In the mouth;
    • From haemorrhoids;
    • In the mouth or blood in sputum when coughing;
    • Into the brain or spinal cord;
    • In the lungs;
    • Into muscle;
  • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring and a dark ring around the edge) (erythema multiforme);
  • Vasculitis, which may cause skin rash or raised, flat, circular, red spots beneath the skin surface or bruising;
  • Blood test results may indicate:
    • Increased gamma-glutamyl transferase (GGT) activity;
    • Presence of blood in stool or urine;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse reactions

After authorisation of the medicinal product, it is important to report suspected adverse reactions. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.

Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Avoclod

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister marked EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed Avoclod tablets are stable in water, 5% glucose solution in water, apple juice, and apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package contents and other information What does Avoclod contain?

  • The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
  • Other ingredients are:
    Tablet core: microcrystalline cellulose type 101, anhydrous lactose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate.
    Tablet coating: hypromellose type 2910, monohydrate lactose, titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Avoclod looks like and contents of the pack
Yellow, oval coated tablets with a diameter of 6.2 mm ± 0.2 mm.
PVC/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 10, 14, 20, 28, 30, 56, 60, 90, 100, 120, 168 and 200 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
PLA 3000 Paola
Malta

This medicinal product is authorised for sale in the European Economic Area under the following names:
Bulgaria: Авоклод
Croatia, Greece, Poland, Czech Republic, Romania, Slovakia, Hungary: Avoclod

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00

Date of last revision: November 2025